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510(k) Data Aggregation
(316 days)
The Spectre System is intended for use with compatible diagnostic x-ray systems in hospitals or outpatient facilities. The Spectre System is indicated for use as an accessory to provide input control to compatible x-ray systems. This accessory includes a wireless footswitch, a wireless hand switch, and a receiver. It is cleared for use for the particular indications of the x-ray system to which it is attached.
The Spectre System is an alternate option to the existing cabled foot switch and hand switch for users of Xray systems. It consists of three parts-a footswitch/transmitter, a hands switch/transmitter, and a receiver. The Spectre system receiver connects to the x-ray system through the same connector as the current footswitch, and operates the x-ray system by exactly emulating the functionality of the current cabled footswitch and hand switch. There are no cables, therefore, no trip hazards, contamination hazards, or cable breakage hazards. The footswitch and hand switch are powered by batteries, eliminating shock hazards. The receiver is mounted on the predicate device, and is powered from the predicate device.
Here's an analysis of the provided text regarding the Spectre Wireless Encrypted Footswitch and Hand switch System, outlining the acceptance criteria and the study that demonstrates its compliance:
The document describes the Spectre System as an alternative option to existing cabled footswitches and hand switches used with X-ray systems. It aims to eliminate trip hazards, contamination hazards, and cable breakage associated with traditional cabled devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Goal | Reported Device Performance (from "Non clinical testing in our facility") | Supporting Documentation |
|---|---|---|
| Functional Equivalence: The Spectre system must perform identically to the predicate cabled footswitch and hand switches. | "Test results showed in each individual condition that the Spectre system performed identically to the predicate devices." | Section VI. Rationale for Substantial Equivalence |
| Reliable Operation: The system must function reliably over time. | "Long term testing using the Spectre system over a period of weeks also produced reliable functionality results from the system. During these tests, no malfunction was recorded." | Section VI. Rationale for Substantial Equivalence |
| No Malfunctions during Iterative Testing: The system should not exhibit malfunctions during repeated signal configurations. | "100 iterations of each possible signal configuration were tested. There were no malfunctions noted during the tests." | Section VI. Rationale for Substantial Equivalence |
| Safety: Elimination of trip hazards, contamination hazards, and shock hazards. | "elimination the contamination hazards of cables as well as improving the overall performance record of the predicate device, thus making it a safer device by eliminating the cables." | Section VII. Safety and Effectiveness Information |
| Conformance to Electrical Safety Standards (IEC 60601-1): The device must meet general requirements for medical electrical equipment safety. | "All design, testing, manufacturing and documentation was performed in conformance with IEC 60601-1... Independent testing was conducted by Underwriter's Laboratories, Inc... These tests concluded that this system complies and conforms to all applicable sections of this standard." | Section VIII. Conformance to Standards |
| Conformance to EMC Standards (IEC 60601-1-2 and related): The device must meet electromagnetic compatibility requirements for medical devices. | "Additional testing by an independent Laboratory demonstrates compliance to the following standards: IEC 60601-1-2 Medical Device (ed 2.1) (2004) which includes IEC 61000-4-2... These tests concluded that the Spectre System is in conformance to FCC Standards, and all applicable sections of IEC 60606-1-1-2 Medical Device (ed 2.1) 2004." | Section VIII. Conformance to Standards |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The primary functional testing involved 100 iterations of each possible signal configuration for the Spectre system. The number of unique signal configurations is not explicitly stated, but the "100 iterations" refers to repeated testing of each command.
- Data Provenance: The document explicitly states, "Non clinical testing in our facility included the installation of the Spectre system onto the predicate devices listed, and conducting functional testing of the Spectre system..." This indicates the testing was retrospective and conducted in-house by TransAmerican Medical Imaging. Independent testing was also conducted by Underwriter's Laboratories, Inc. and "an independent Laboratory" for standards compliance. The country of origin for the functional testing data is likely the USA (Lindon, UT), where TransAmerican Medical Imaging is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for this type of device. The ground truth for functional equivalence was based on direct comparison to the "exact functionality of the current cabled footswitch and hand switch." The testing was technical in nature, verifying signal transmission and system response, rather than diagnostic interpretation requiring clinical experts.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing was non-clinical and focused on functional and electrical performance. There was no subjective assessment requiring multiple reviewers or a consensus process.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically relevant for diagnostic imaging devices where the performance of human readers (with and without AI assistance) is evaluated in interpreting medical images. The Spectre System is an accessory to X-ray systems, focused on control input, not diagnostic interpretation.
6. Standalone Performance Study
Yes, a standalone study was done in the context of the device's functional and standards compliance.
- Functional Testing: "Non clinical testing in our facility included... conducting functional testing of the Spectre system to insure exact functional performance as compared to the predicate footswitch and hand switches." This demonstrates the algorithm-only performance in emulating the predicate device's signals.
- Standards Compliance: Independent laboratories (UL and another unspecified independent lab) conducted testing solely on the Spectre System to ensure its conformance to electrical safety and EMC standards.
7. Type of Ground Truth Used
The ground truth used was primarily functional equivalence to established predicate devices.
- For the functional testing, the "ground truth" was the expected and demonstrated behavior of the standard cabled footswitch and hand switch. The Spectre system was designed to "exactly emulat[e] the functionality" of these predicate devices.
- For safety and EMC, the ground truth was defined by the requirements of international standards (IEC 60601-1, IEC 60601-1-2, etc.).
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The Spectre System is a hardware accessory with embedded firmware designed to emulate existing hardware functionality. It does not use machine learning or AI algorithms that require a training set to "learn" patterns or make predictions. Its design and "knowledge" are hard-coded based on the existing functionality of cabled footswitches.
9. How the Ground Truth for the Training Set Was Established
As noted above, there was no training set for this device in the context of machine learning. The "ground truth" for its development was the pre-existing, well-understood functional specifications and electrical characteristics of standard cabled footswitches and hand switches used with X-ray systems. The device was engineered to meet these established specifications.
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